BEUDAMED
    FDA Enforcement Class II Terminated

    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

    Recall: Z-2075-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2075-2021
    Event ID
    88084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C-RAD POSITIONING AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 21, 2021
    Initiation Date
    August 6, 2020
    Classification Date
    July 14, 2021
    Termination Date
    April 15, 2022
    Address
    Bredgrand 18, Uppsala, N/A, Sweden

    Description

    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

    Reason

    PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

    Code Info

    Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0

    Distribution

    US Nationwide distribution in the states of IL, KY, MO and WA.

    Quantity

    7